MAUDE Adverse Event Report: AUTOSOFT 90 UNO INSET II 60/6 GREY TCAP 10PK INT

Model Number 1002817

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

Unomedical reference number (b)(4). Event occurred in the united states. It was reported that on (b)(6) 2021 and (b)(6) 2021, the patient's infusion set's tubing detached/broken at site connector. At the time of the first event, his blood glucose level was between 100-200 mg/dl and the infusion set had been used for 24 hours. However, at the time of the second event, his blood glucose level was 230 mg/dl and the infusion set had been used for one and a half days. Further, they replaced the infusion set and insulin was resumed successfully. No further information available.

• Brand Name: AUTOSOFT 90
• Type of Device: UNO INSET II 60/6 GREY TCAP 10PK INT
• Manufacturer Contact: aaholmvej 1-3; osted; lejre, 4320
• MDR Report Key: 12881218
• MDR Text Key: 281314095
• Report Number: 3003442380-2021-00762
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): Y
• PMA/PMN Number: K032854
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor

Reporter Occupation

• Type of Report: Initial
• Report Date: 11/29/2021

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 11/29/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 1002817
• Device Lot Number: 5349738
• Was Device Available for Evaluation?: No Answer Provided
• Date Manufacturer Received: 11/16/2021
• Was Device Evaluated by Manufacturer?: No Answer Provided